Long-Term Evaluation of TAILORED Vs Anatomical Ablation Strategy for Persistent Atrial Fibrillation

NCT06825104 · tracked via the Priya Life Science Germany tracker

Sponsor

Volta Medical

Phase

Observational

Started

2025-03-06

Last updated

2025-03-13

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Volta AF-XplorerDispersion ablation + PVIPVI

Volta AF-Xplorer: Dispersion ablation strategy guided by Volta Medical AI-software targeting areas of spatiotemporal dispersed electrograms

Dispersion ablation + PVI: TAILORED-AF index procedure: Dispersion ablation + PVI

PVI: TAILORED-AF index procedure: PVI only

Study summary

The TAILORED-LT study is conducted as an extension follow-up until 5 years of the initial TAILORED-AF study (NCT04702451), in order to demonstrate the long-term superiority in terms of freedom of atrial fibrillation (AF) of a tailored ablation strategy targeting areas of spatio-temporal dispersed electrograms in combination with pulmonary veins isolation (PVI) over an anatomical ablation strategy targeting PVI alone for the initial ablation procedure of persistent AF.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient who participated in the Tailored AF study * Patient not withdrawn during the 12-month follow-up period post-index procedure in the Tailored AF study * Patient able and willing to provide written informed consent to participate in this extension Tailored-LT study Exclusion Criteria: * Person deprived of liberty or under guardianship * Person unable to undergo a medical monitoring for geographical, social or psychological reasons

Primary outcome measure(s)

Long-term freedom from documented atrial fibrillation (AF) after one ablation procedure — 60 months
Long-term freedom from documented AF episodes \> 30 seconds, with or without antiarrhythmic drugs (AADs), after a single index ablation procedure.

Trial sites (13)

Facility	City	Region	Status
CHU Lyon, Hôpital Louis Pradel	Bron	France	Not Yet Recruiting
Pôle Santé République	Clermont-Ferrand	France	Not Yet Recruiting
Hôpital Saint Philibert	Lomme	France	Not Yet Recruiting
Hôpital Saint-Joseph Marseille	Marseille	France	Recruiting
Hôpital Privé Jacques Cartier	Massy	France	Not Yet Recruiting
Hôpital Privé du Confluent	Nantes	France	Not Yet Recruiting
Polyclinique Saint George	Nice	France	Not Yet Recruiting
Centre Cardiologique du Nord	Saint-Denis	France	Not Yet Recruiting
Clinique Rhéna	Strasbourg	France	Not Yet Recruiting
Clinique Pasteur	Toulouse	France	Not Yet Recruiting
CHRU Nancy, Institut Lorrain du coeur et des vaisseaux	Vandœuvre-lès-Nancy	France	Not Yet Recruiting
Klinikum Coburg	Coburg	Germany	Not Yet Recruiting
German Heart Center	Munich	Germany	Not Yet Recruiting

More Volta Medical trials in Germany

Clinical and Healthcare Economic OutcoMes From ReAl-worlD Use in Europe of an AI Software During AF Ablation Active, not recruiting

Other trials for the same condition

Non-invasive Differentiation of Supraventricular Tachyarrhythmia Recruiting

Clinical Cohort Study - TRUST Recruiting

Early Treatment of Atrial Fibrillation for Stroke Prevention Trial in Acute STROKE Recruiting

VOLT CE Mark Study Active, not recruiting

Anticoagulation for New-Onset Post-Operative Atrial Fibrillation After CABG Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06825104 on ClinicalTrials.gov ↗ ← All trials in Germany